Be an early applicantLess than 25 applicants

Company

Cedars-Sinai · 1 day ago

Sr. Regulatory Coordinator -The Angeles Clinic & Research Institute

Santa Monica, CA

Full-time

Remote

Mid, Senior Level

$29.95/hr - $46.42/hr

3+ years exp

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Responsibilities

Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.

Completes forms and generates reports from multiple data sources to comply with the assigned protocals for the study and/or clinical trail.

Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trails.

Responds to generally broad data requests and questions.

Monitors the status of assigned regulatory submissions and amendments from end-to-end.

Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date.

Represents the unit in cross functional meetings and provides updates on the status of assigned regulatory submissions.

Supports the unit in internal and external auditing of regulatory documents.

Identifies quality and performance improvement opportunities to support efficient workflows.

Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines.

Qualification

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Research ExperienceRegulatory ComplianceClinical Research Certification (CCRP)Clinical Practice (GCP)Data ManagementPatient ConfidentialityAuditing SkillsCross-Functional Collaboration

Required

Bachelor's Degree Required

3 years relative experience in a research related field required

Preferred

Certification In Clinical Research (CCRP)

Company

Cedars-Sinai

Glassdoor

4.0

Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards for quality and innovation in patient care, research, teaching and community service.

Founded in 1902

Los Angeles, California, USA

10001+ employees